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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075566
Company: UPSHER SMITH LABS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Discontinued None No No
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Discontinued None No No
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Discontinued None No No
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Discontinued None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/08/2004 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/26/2009 SUPPL-7 Labeling

Label is not available on this site.
04/21/2009 SUPPL-6 Labeling

Label is not available on this site.
05/17/2005 SUPPL-4 Labeling

Label is not available on this site.
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